SupplementNCT01971723

Multi-ingredient Supplement for Strength and Power

A study testing T+ Supplement in people with Supplement, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Supplement
What is being tested?: T+ Supplement
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Must be familiar with the three main powerlifting movements (squat, bench and deadlift)
Must have one month training with a designated strength coach to understand the expectations of the strength coach and movement patterns for performance
Have no pre-existing musculoskeletal disorders
Participate in the three-week supplement wash out prior to beginning the experiment (except for basic protein supplements and multivitamins)

Who cannot join

Female

Trial locations and contacts

1 site in 1 country.

United States1 site

Florida State University
Tallahassee, Florida, 32306

Other trials in United States

About this study

Official title: The Impact of T+ Supplementation on Anabolic Hormone Profile and Performance in Power Athletes

It has been suggested that high amounts of total serum testosterone levels correlate with higher lean body mass, lowered fat mass, greater muscle strength, and faster recovery. These suggestions drive athletes and body builders to find ways to raise their testosterone levels. Many athletes and bodybuilders look to alternative methods to anabolic steroids in order increase their testosterone levels without legal repercussions or physiological side effects. Herbs and other plant extracts have been introduced as a possible source to naturally boost testosterone levels. Research supporting the use of herbs and plant extracts has been shown to be equivocal. However, evidence in studies with hypogonadal men suggests that longjack root may naturally boost testosterone levels.

Onnit Labs, LLC has packaged this supplement (T+) which claims it can naturally boost testosterone and lower estrogen levels and subsequently improve performance. This product is a powder (11g) that is mixed with 16 oz of water and consumed 20 minutes prior to anaerobic workouts, such as high intensity weight training.

T+ is a multi-ingredient supplement that consists of vitamins B5 and B6, magnesium aspartic acid, mucuna pruriens, longjack root, nettle root, red clover luteolin, resveratrol, beta- alanine, branch chain amino acids, L- glutamine, Bioperine, and Fibersol 2.

The active ingredients purported to boost plasma testosterone levels are mucuna pruriens, longjack root, and magnesium aspartic acid. The active ingredients claimed to lower plasma estrogen concentrations are red clover, luteolin, resveratrol and nettle root. All other ingredients (Branch Chain Amino Acids and Beta-Alanine) have been documented to improve exercise performance.

It is hypothesized that there will not be any physiological changes after supplementation of T+. It is also hypothesized that performance will not be affected by the supplementation of T+.

Read the detailed description

The purpose of this study is to examine the physiological and performance effects of T+ on power athletes.

Conditions: Supplement
Being tested: T+ Supplement, Placebo
Keywords: Testosterone, Estrogen, Insulin, Blood Lipid, Glucose, Creatine Kinase, Strength, Power Athlete
Medical subject headings: Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T+ SupplementOther
Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days).
PlaceboOther
The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group.

Study groups in NCT01971723
Study group	Role	What they receive
T+ Supplement	Active comparator	This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment. Receives: Other: T+ Supplement
Placebo	Placebo comparator	This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Strength Performance Outcomes
Measurement of one repetition maximums strength for all competition lifts included in a standard, ungeared, powerlifting competition (squat, bench, and deadlift). This testing will take place before the supplementation of either T+ or placebo and at the end of the four-week training period.
Each measure was only compared within it's own category against the baseline measurement and against that of the other group at the same time point.
Measured: Baseline measures and 4 weeks from start of study
Insulin Outcomes
Measurements of insulin will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Measured: Baseline, 2-week mark, 4-week mark
Blood Lipid Outcomes
Measurements for blood lipid panels will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Measured: Baseline, 2-week mark, 4-week mark
Total Testosterone Outcomes
Measurements for testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Measured: Baseline, 2-week mark, 4-week mark
Estrogen Outcomes
Measurements for estrogen will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Measured: Baseline, 2-week mark, 4-week mark
Insulin-like Growth Factor-I Outcomes
Measurements for insulin-like growth factor-I will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Measured: Baseline, 2-week mark, 4-week mark
Bio-availableTestosterone Outcomes
Measurements for total testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Measured: Baseline, 2-week mark, 4-week mark
Free Testosterone Outcomes
Measurements for free testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Measured: Baseline, 2-week mark, 4-week mark
Dihydrotestosterone Outcomes
Measurements for dihydrotestosterone (DHT) will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Measured: Baseline, 2-week mark, 4-week mark
Cortisol Outcomes
Measured: Baseline, 2-week mark, 4-week mark
Sex-hormone Binding Globulin Outcomes
Measured: Baseline, 2-week mark, 4-week mark
Creatine-Kinase Outcomes
Measured: Baseline, 2-week mark, 4-week mark

Secondary outcomes (1)

Volume Performance Outcomes
During the four weeks, the volume ((weight x reps)set 1+(weight x reps)set 2+ (weight x reps)set 3….. ) will be calculated and measured for each exercise in each lifting session.
Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Dec 2015

First posted29 Oct 2013 (estimated)
Study startJun 2013
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SupplementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01971723
Sponsor's protocol ID: HSC#: 2013.10364
Status last verified: Feb 2016
First submitted: 27 Aug 2013
Last updated: 29 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kreipke VC, Allman BR, Kinsey AW, Moffatt RJ, Hickner RC, Ormsbee MJ. Impact of Four Weeks of a Multi-Ingredient Performance Supplement on Muscular Strength, Body Composition, and Anabolic Hormones in Resistance-Trained Young Men. J Strength Cond Res. 2015 Dec;29(12):3453-65. doi: 10.1519/JSC.0000000000000995.
PubMed 26595135

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of T+ Supplementation on Anabolic Hormone Profile and Performance in Power Athletes
ClinicalTrials.gov ID: NCT01971723
Acronym / sponsor ID: HSC#: 2013.10364
Conditions: Supplement
Keywords: Testosterone, Estrogen, Insulin, Blood Lipid, Glucose, Creatine Kinase, Strength, Power Athlete
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Florida State UniversityUniversity, hospital or other
Collaborators: East Carolina University
Study start: Jun 2013
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 29 Oct 2013 (estimated)
Results: Posted 13 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

It is hypothesized that there will not be any physiological changes after supplementation of T+. It is also hypothesized that performance will not be affected by the supplementation of T+.

Detailed description

The purpose of this study is to examine the physiological and performance effects of T+ on power athletes.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
T+ Supplement	Active comparator	Other: T+ SupplementThis arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
Placebo	Placebo comparator	Other: PlaceboThis arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Must be familiar with the three main powerlifting movements (squat, bench and deadlift)
Must have one month training with a designated strength coach to understand the expectations of the strength coach and movement patterns for performance
Have no pre-existing musculoskeletal disorders
Participate in the three-week supplement wash out prior to beginning the experiment (except for basic protein supplements and multivitamins)

Key exclusion criteria (1 listed)

Female

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T+ SupplementRandomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days).	Other	T+ Supplement
PlaceboThe placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group.	Other	Placebo

Primary outcome

Strength Performance Outcomes
Time frame: Baseline measures and 4 weeks from start of study
Measurement of one repetition maximums strength for all competition lifts included in a standard, ungeared, powerlifting competition (squat, bench, and deadlift). This testing will take place before the supplementation of either T+ or placebo and at the end of the four-week training period. Each measure was only compared within it's own category against the baseline measurement and against that of the other group at the same time point.
Insulin Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Measurements of insulin will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Blood Lipid Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Measurements for blood lipid panels will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Total Testosterone Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Measurements for testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Estrogen Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Measurements for estrogen will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Insulin-like Growth Factor-I Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Measurements for insulin-like growth factor-I will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Bio-availableTestosterone Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Measurements for total testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Free Testosterone Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Measurements for free testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Dihydrotestosterone Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Measurements for dihydrotestosterone (DHT) will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.
Cortisol Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Sex-hormone Binding Globulin Outcomes
Time frame: Baseline, 2-week mark, 4-week mark
Creatine-Kinase Outcomes
Time frame: Baseline, 2-week mark, 4-week mark

1 secondary outcome

Volume Performance Outcomes
Time frame: 4 Weeks

Results and safety

Results posted to the registry on 13 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T+ Supplement	16	14
Placebo	16	13

Primary outcome: Strength Performance Outcomes

Time frame: Baseline measures and 4 weeks from start of study. Mean (Standard Deviation). Unit: Kg

Measure	T+ Supplement n = 14	Placebo n = 13
Baseline Squat	119.48 (24.84)	120.45 (29.82)
Post Training Squat	132.47 (26.72)	129.37 (28.98)
Baseline Bench	102.27 (15.75)	96.33 (22.01)
Post Training Bench	108.44 (16.30)	100.87 (21.69)
Baseline Deadlift	157.79 (23.05)	169.93 (30.07)
Post Training Deadlift	171.59 (22.42)	169.93 (30.07)
Baseline Total	379 (58.61)	375.87 (70.07)
Post Training Total	412.5 (60.17)	400.17 (75.03)

T+ Supplement vs Placebo: p = .38, ANOVA
T+ Supplement vs Placebo: p = 0.0001, ANOVA
T+ Supplement vs Placebo: p = .3, ANOVA

Primary outcome: Insulin Outcomes

Time frame: Baseline, 2-week mark, 4-week mark. Mean (Standard Deviation). Unit: ulU/ml

Measure	T+ Supplement n = 14	Placebo n = 13
Baseline Levels	5.70 (3.42)	5.83 (2.73)
Mid Training Levels	5.68 (4.51)	5.34 (2.39)
Post Training Levels	5.52 (2.3)	6.51 (2.67)

T+ Supplement vs Placebo: p >.05, ANOVA

Primary outcome: Blood Lipid Outcomes

Time frame: Baseline, 2-week mark, 4-week mark. Mean (Standard Deviation). Unit: mg/dl

Measure	T+ Supplement n = 14	Placebo n = 13
Cholesterol Baseline	158 (28)	162 (31)
Cholesterol Mid Training	161 (26)	160 (29)
Cholesterol Post Training	162 (27)	161 (26)
Glucose Baseline	93 (11)	98 (12)
Glucose Mid Training	96 (6)	94 (14)
Glucose Post Training	97 (9)	96 (11)
HDL Basline	47 (8)	50 (8)
HDL Mid Training	47 (8)	50 (9)

T+ Supplement vs Placebo: p >.05, ANOVA
T+ Supplement vs Placebo: p >.05, ANOVA
T+ Supplement vs Placebo: p >.05, ANOVA

Primary outcome: Total Testosterone Outcomes

Time frame: Baseline, 2-week mark, 4-week mark. Mean (Standard Deviation). Unit: ng/dL

Measure	T+ Supplement n = 14	Placebo n = 13
Pre Training Levels	564 (146)	473 (129)
Mid Training Levels	525 (116)	415 (90)
Post Training Levels	548 (148)	475 (129)

T+ Supplement vs Placebo: p >.05, ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Reports were only collected during the 4 weeks of training.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T+ Supplement	0 of 14 (0%)	5 of 14 (35.7%)	Not reported
Placebo	0 of 13 (0%)	0 of 13 (0%)	Not reported

Limitations and caveats (from the sponsor): Unable to standardize individual ingredients in T+ supplement. Volume of lifts not tested was not analyzed for statistical significance. Neuromuscular adaptations were not tested. Length of study may have affected body composition measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26595135Kreipke VC, Allman BR, Kinsey AW, Moffatt RJ, Hickner RC, Ormsbee MJ. Impact of Four Weeks of a Multi-Ingredient Performance Supplement on Muscular Strength, Body Composition, and Anabolic Hormones in Resistance-Trained Young Men. J Strength Cond Res. 2015 Dec;29(12):3453-65. doi: 10.1519/JSC.0000000000000995.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J Ormsbee, PhD principal investigator

Florida State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing T+ Supplement in people with Supplement, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Strength Performance Outcomes (time frame: Baseline measures and 4 weeks from start of study). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01971723, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016; AzTrials last refreshed its copy on 28 Oct 2026.